DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office Action is responsive to the Amendment filed 29 October 2025. Claims 1-8 and 11-28 are currently under consideration. The Office acknowledges the amendments to claims 1, 3, 13, 14, 20, and 21, as well as the cancellation of claims 9 and 10, and the addition of new claims 22-28.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-8, 11, and 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Giladi et al. (U.S. Pub. No. 2018/0008708 A1; cited in the IDS filed 21 September 2022; hereinafter known as “Giladi”), in view of Cade et al. (U.S. Pub. No. 2017/0000795 A1; hereinafter known as “Cade”).
Regarding claim 1, Giladi discloses a method of treating cancer in a subject (Abstract), comprising: delivering radiation therapy to an organ of the subject, wherein the organ contains at least one cancer cell, applying alternating electric fields to the organ at a frequency of 50 kHz to 10 MHz, wherein the method comprises applying alternating electric fields prior to delivering the radiation therapy, and administering systemic cancer therapy to the subject ([0005]-[0014]; [0051]). Giladi fails to disclose that the radiation therapy comprises delivering radioactive particles to the organ of the subject. Cade teaches a similar method of treating cancer in a subject that includes systemic cancer therapy (Abstract) and that treats liver cancer via radiation therapy that comprises delivering radioactive particles to the liver in order to provide improved treatment of liver cancer ([0006]-[0008]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Giladi so that the radiation therapy delivers radioactive particles to the organ, as taught by Cade, in order to provide improved treatment of liver cancer.
Regarding claim 2, the combination of Giladi and Cade discloses the invention as claimed, see rejection supra, and Cade further discloses that the cancer is colorectal cancer that has metastasized to a liver of the subject, and wherein the radioactive particles are delivered to the liver ([0001]; [0003]; [0008]; [0058]; [0117]; [0132]).
Regarding claim 3, the combination of Giladi and Cade discloses the invention as claimed, see rejection supra, and Giladi further discloses that the alternating electric field has a frequency between 100 and 300 kHz ([0007]; [0010]).
Regarding claim 4, the combination of Giladi and Cade discloses the invention as claimed, see rejection supra, and Cade further discloses that the radioactive particles comprise at least one of resin-based microspheres and glass-based microspheres ([0006]; [0120]; [0136]).
Regarding claim 5, the combination of Giladi and Cade discloses the invention as claimed, see rejection supra, and Giladi further discloses that at least a portion of the applying step is performed simultaneously with at least a portion of the delivering step ([0009]; [0014]; [0049]-[0050]).
Regarding claim 6, the combination of Giladi and Cade discloses the invention as claimed, see rejection supra, and Giladi further discloses that the alternating electric fields are applied for at least 18 hours ([0033]; [0044]).
Regarding claims 7 and 8, the combination of Giladi and Cade discloses the invention as claimed, see rejection supra, and Cade further discloses that the organ is located in an abdomen or a head of the subject, wherein the organ is a liver, a spleen, or a pancreas ([0001]; [0003]; [0008]; [0058]; [0117]; [0132]).
Regarding claim 11, the combination of Giladi and Cade discloses the invention as claimed, see rejection supra, and further discloses that the systemic cancer therapy comprises administering a chemotherapeutic agent to the subject (Giladi: [0006], [0011], [0026]; Cade: [0093]-[0094]).
Regarding claim 21, the combination of Giladi and Cade discloses the invention as claimed, see rejection supra, and Giladi further discloses that the intensity of the alternating electric fields is 0.1 to 20 V/cm (RMS) for at least a portion of a region to which the alternating electric fields are applied ([0007]; [0013]; [0048]; [0051]).
Regarding claim 22, the combination of Giladi and Cade discloses the invention as claimed, see rejection supra, and Giladi further discloses that the intensity is 0.5 to 10 V/cm (RMS) ([0007]; [0013]; [0048]; [0051]).
Regarding claim 23, the combination of Giladi and Cade discloses the invention as claimed, see rejection supra, and Giladi further discloses that the intensity is 1.0 to 2.5 V/cm (RMS) ([0007]; [0013]; [0048]; [0051]).
Regarding claim 24, the combination of Giladi and Cade discloses the invention as claimed, see rejection supra, and Giladi further discloses that the alternating electric field has a frequency between 120 kHz to 180 kHz ([0007]; [0013]; [0048]; [0051]).
Regarding claim 25, the combination of Giladi and Cade discloses the invention as claimed, see rejection supra, and Giladi further discloses that the alternating electric field has a frequency of 150 kHz ([0007]; [0013]; [0048]; [0051]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Giladi and Cade as applied to claim 11 above, and further in view of Agah et al. (U.S. Pub. No. 2018/0333563 A1; hereinafter known as “Agah”). The combination of Giladi and Cade discloses the invention as claimed, see rejection supra, but fails to expressly disclose that the chemotherapeutic agent comprises at least one of regorafenib and trifluridine. Agah teaches a similar method of treating cancer in a subject (Abstract) and that approved drugs for treating colorectal cancer that has metastasized to the liver include oxaliplatin, 5-FU, folfiri, irinotecan, or leucovorin (as in Cade), as well as regorafenib and trifluridine ([0018]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Giladi and Cade so that the chemotherapeutic agent comprises at least one of regorafenib and trifluridine, as taught by Agah, as these are known effective approved chemotherapeutic agents for treating this type of cancer and thus would have been a simple substitution of one known element for another with predictable results.
Claims 13-16, 19, 20, 26, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Travers et al. (U.S. Pub. No. 2021/0177492 A1; hereinafter known as “Travers”), in view of Chang et al. (U.S. Pub. No. 2020/0009377 A1; hereinafter known as “Chang”).
Regarding claim 13, Travers discloses a method of preventing recurrence of cancer in a subject that has been previously treated for cancer (Abstract; [0023]) comprising applying alternating electric fields to an organ of the subject at a frequency of 50 kHz to 10 MHz ([0006]; [0010]; [0059]), wherein the previously treated cancer is a primary cancer or a metastatic cancer ([0002]; [0010]; [0024]). Travers fails to disclose that the fields are applied for a period of at least three months. Chang teaches a similar method (Abstract) that applies alternating electric fields to an organ of the subject at a frequency of 50 kHz to 10 MHz for several months in order to improve the effectiveness of the treatment ([0111]; [0120]; “long periods of time e.g., weeks or months” and “many months” are taken to reasonably encompass a period of at least three months). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Travers so that the alternating electric fields are applied for at least three months, as taught by Chang, in order to improve the effectiveness of the treatment.
Regarding claim 14, the combination of Travers and Chang discloses the invention as claimed, see rejection supra, and Travers further discloses that the frequency of the alternating electric fields is from 100 kHz to 300 kHz ([0006]; [0010]; [0059]).
Regarding claims 15 and 16, the combination of Travers and Chang discloses the invention as claimed, see rejection supra, and Travers further discloses that the organ is located in an abdomen or a head of the subject, wherein the organ is a liver, a spleen, or a pancreas ([0064]).
Regarding claim 19, the combination of Travers and Chang discloses the invention as claimed, see rejection supra, and Chang further discloses administering systemic cancer therapy to the subject in order to provide therapeutic additivity and synergy ([0088]; [0106]-[0108]; [0124]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination of Travers and Chang by administering systemic cancer therapy to the subject, as taught by Chang, in order to provide therapeutic additivity and synergy.
Regarding claim 20, the combination of Travers and Chang discloses the invention as claimed, see rejection supra, and Chang further discloses that the systemic cancer therapy comprises administering to the subject a chemotherapeutic agent ([0088]; [0106]-[0108]; [0124]).
Regarding claims 26 and 27, the combination of Travers and Chang discloses the invention as claimed, see rejection supra, and Travers further discloses that the alternating electric field has a frequency between 120 kHz to 180 kHz or a frequency of 150 kHz ([0006]; [0010]; [0059]).
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Travers and Chang as applied to claim 13 above, and further in view of Cade.
Regarding claim 17, the combination of Travers and Chang discloses the invention as claimed, see rejection supra, but fails to disclose delivering radioactive particles to the organ. Cade teaches a similar method (Abstract) that treats liver cancer (as in Travers) via delivering radioactive particles to the liver in order to provide improved treatment of liver cancer ([0006]-[0008]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Travers and Chang by delivering radioactive particles to the organ, as taught by Cade, in order to provide improved treatment of liver cancer.
Regarding claim 18, the combination of Travers, Chang, and Cade discloses the invention as claimed, see rejection supra, and Cade further discloses that the radioactive particles comprise at least one of resin-based microspheres and glass-based microspheres ([0006]; [0120]; [0136]).
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Travers and Chang as applied to claim 13 above, and further in view of Agah. The combination of Travers and Chang discloses the invention as claimed, see rejection supra, but fails to disclose that the chemotherapeutic agent is one or more of regorafenib and trifluridine. Agah teaches a similar method (Abstract) and that approved chemotherapeutic drugs for treating liver cancer include regorafenib and trifluridine ([0018]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Travers and Chang so that the chemotherapeutic agent comprises at least one of regorafenib and trifluridine, as taught by Agah, as these are known effective approved chemotherapeutic agents for treating this type of cancer (liver cancer being taught by Travers) and thus would have been a simple substitution of one known element for another with predictable results.
Response to Arguments
Applicant’s arguments with respect to the rejections under 35 U.S.C. 112(a) have been fully considered and are persuasive. The rejections have been withdrawn.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 112(b) have been fully considered and are persuasive in light of the amendments. The rejections have been withdrawn.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102 and 103 have been fully considered and are persuasive in light of the amendments. Therefore, the rejections have been withdrawn. However, upon further consideration, new grounds of rejection are made, as detailed supra.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791